BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS E MODULE

    MDR report key: 964222 · Received December 13, 2007

    Report

    Report Number
    1823260-2007-10711
    Event Type
    Malfunction
    Date Received
    December 13, 2007
    Date of Event
    November 20, 2007
    Report Date
    December 13, 2007
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT FREE T3 RESULT OF 7.99 P/ML, DOES NOT FIT CLINICAL PICTURE. SAMPLE WAS REPEATED USING THE SAME METHOD GAVE 6.98 P/ML, AND BY ANOTHER METHOD GIVING 3.78 P/ML. IF ADD'L INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ANALYTICS E MODULE IMMUNOCHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS CORP. E170

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR